Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.
Showing 8061–8080 of 17,773 recalls
Aurobindo Pharma USA Inc.
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Aurobindo Pharma USA Inc.
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.